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Medical & Healthcare
Precision
for
Life
ISO 13485-certified manufacturing for medical devices and healthcare equipment. From surgical instruments to implantables, we deliver life-critical components with uncompromising quality.
Regulatory Compliance
ISO 13485
Medical QMS
FDA Reg
US Compliance
ISO 9001
Quality Standard
Clean Room
ISO Class 7/8
Facility Tour
Where Precision Meets Patient Safety
Tour our FDA-registered facility and see how our validated processes, clean room manufacturing, and rigorous quality systems deliver components that meet the highest medical standards.
ISO 13485 Certified
Clean Room Mfg
Full Traceability
FDA Registered
About Us
Trusted Partner for Life-Critical Manufacturing
For over 20 years, we've been the trusted manufacturing partner for medical device companies worldwide. Our ISO 13485 certified quality system, clean room capabilities, and experienced team deliver the precision and reliability that life-critical applications demand.
From Class I to Class III devices, we understand the regulatory requirements and documentation needs of the medical industry.
20+
Years Medical Exp
100%
Traceability
50+
Device Partners
FDA Compliant
Regulatory excellence
Our Process
Validated Manufacturing Excellence
Step 01
Design Review
DFM analysis, biocompatibility assessment, and regulatory compliance mapping
Step 02
Process Validation
IQ/OQ/PQ protocols, risk assessment (FMEA), and DHR documentation preparation
Step 03
Controlled Manufacturing
Clean room production, validated processes, and in-process controls per ISO 13485
Step 04
Quality Verification
CMM inspection, surface analysis, and material certification with full lot traceability
Step 05
Compliant Delivery
Validated packaging, sterile transfer, and complete DHR documentation
What We Do
Complete Medical Device Manufacturing
From surgical instruments to implantable devices, we provide precision manufacturing solutions that meet the stringent requirements of the medical industry.
Request a QuoteSurgical Instruments
Precision-machined surgical tools, orthopedic instruments, and minimally invasive device components from titanium and stainless steel
Implantable Devices
FDA-compliant manufacturing of orthopedic implants, spinal devices, and cardiovascular components with full traceability
Diagnostic Equipment
Components for MRI, CT, X-ray, and ultrasound equipment including housings, frames, and precision mechanisms
Drug Delivery Systems
Insulin pumps, infusion devices, and inhalation system components manufactured in controlled environments
Patient Care Equipment
Hospital beds, patient lifts, surgical tables, and rehabilitation equipment structural components
Laboratory Equipment
Precision components for analyzers, centrifuges, and automated lab systems with tight tolerances
FAQ'sFrequently Asked Questions
We maintain the certifications required for medical device manufacturing:
- ISO 13485:2016 certified quality management system for medical devices
- FDA registered manufacturing facility with current compliance
- ISO Class 7 and Class 8 clean room manufacturing capability
- Full design history file (DHF) and device master record (DMR) support
We specialize in biocompatible materials for medical devices:
- Titanium alloys (Ti-6Al-4V ELI, CP Ti) for implants and instruments
- Medical-grade stainless steels (316L, 17-4PH, 455) for surgical tools
- Cobalt-chrome alloys (CoCrMo) for orthopedic implants
- PEEK, Ultem, and engineering plastics for device components
Yes, we provide complete documentation for regulatory compliance:
- Device History Records (DHR) with full lot traceability
- Process validation protocols (IQ/OQ/PQ) and reports
- Material certifications with biocompatibility documentation
- First Article Inspection reports and statistical capability data
Our controlled environment manufacturing meets medical requirements:
- ISO Class 7 (Class 10,000) clean room for critical components
- ISO Class 8 (Class 100,000) for general medical device assembly
- Controlled environment machining with filtered air handling
- Validated cleaning and passivation processes
We offer finishes meeting medical device requirements:
- Electropolishing for smooth, corrosion-resistant surfaces
- Passivation per ASTM A967 for stainless steel components
- Anodizing for aluminum components with sealed surfaces
- Laser marking for UDI compliance and traceability
Our traceability system meets medical device requirements:
- Lot-level material tracking from mill certification through shipping
- Serialized part tracking for implantable and critical components
- Electronic DHR with complete manufacturing history
- UDI-compliant labeling and documentation
Engineered for Better Performance.
Get expert guidance to improve design, efficiency, and overall product quality.